EVIDENT MARK 2 APEX LOCATOR
FDA 510(k) clearance K863834 · decided 1987-02-06
Clearance details
- K-number
- K863834
- Device name
- EVIDENT MARK 2 APEX LOCATOR
- Applicant
- Pulpdent Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1986-09-30
- Decision date
- 1987-02-06
- Days to decision
- 129 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Brookline, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.